Cyclacel Pharmaceuticals (CYCC) Q2 2024 earnings summary

Executive summary

• Advanced recruitment in the phase 2 proof of concept study for oral fadraciclib, targeting patients with CDKN2A/B chromosomal abnormalities, with interim clinical activity data expected in Q4 2024.

• Opened a second cohort for T-cell lymphoma based on promising phase 1 signals, including partial responses.

• Fadraciclib demonstrated clinical benefit in heavily pretreated patients across multiple tumor types, with a strong competitive profile in its class.

• Cyclacel is a clinical-stage biopharmaceutical company focused on transcriptional regulation (fadraciclib) and anti-mitotic (plogosertib) therapies.

• Strong investigator interest in the precision medicine cohort, nearing recruitment completion.

Financial highlights

• Cash and cash equivalents totaled $6 million as of June 30, 2024, up from $3.4 million at year-end 2023.

• Net cash used in operations was $3.6 million for the first half of 2024, down from $8.2 million in the same period of 2023.

• Net loss for Q2 2024 was $3.3 million, compared to $5.5 million in Q2 2023.

• R&D expenses for Q2 2024 were $2 million, down from $4.7 million in Q2 2023, with fadraciclib-related R&D at $1.5 million.

• Revenue declined to $4,000 in Q2 2024 from $373,000 in Q2 2023, primarily from clinical manufacturing cost recovery.

Outlook and guidance

• Current cash resources are expected to fund planned programs into Q4 2024, but substantial doubt exists about the ability to continue as a going concern beyond that period without additional capital.

• Initial phase 2 clinical activity data from approximately 12 patients anticipated by year-end 2024.

• Management is actively seeking additional funding through equity, debt, or partnerships.

• Research and development expenses for 2024 are anticipated to decrease further, with focus on clinical trial costs for fadraciclib.

• Success in the first stage of the study defined as at least two responses in the first 12-14 patients, with further expansion if met.